510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821195Substantially Equivalent

Cholesterol Reagent Set

Omega Medical Electronics, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821195 is the FDA 510(k) clearance record for CHOLESTEROL REAGENT SET, a class I device, cleared for Omega Medical Electronics on under FDA product code CHD (Acid, Ferric Ion-Sulfuric, Cholesterol). FDA records list 21 510(k) clearances for Omega Medical Electronics, from to . As of , FDA records show no recalls naming K821195.

Clearance record

Decision date
Received
(77 days to decision)
Product code
CHD Acid, Ferric Ion-Sulfuric, Cholesterol
Regulation
21 CFR 862.1175
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Omega Medical Electronics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CHD

Trailing 12 months

FDA records hold no clearances under product code CHD in the trailing twelve months.

FDA records show no clearances under product code CHD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CHD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260